Lenvatinib brings thyroid cancer patient hope

BY
Lori Baker

Hugh Lokey travels 497 miles each time he comes to MD Anderson for thyroid cancer treatment. Then it's 497 miles back home to Broken Arrow, Okla. He's been making the trip for five years, sometimes twice a month.

"It's been tremendously worth it," says Hugh, a 70-year-old Marine Corps veteran who's benefited from, and perhaps even survived because of, lenvatinib. This new thyroid cancer drug was tested here and approved by the Food and Drug Administration (FDA) in February.

Like Hugh, the drug had a long journey, and each step was taken at MD Anderson.

New hope after decades with one treatment
Until recently, patients with radioiodine-refractory thyroid cancer had only one treatment option. And it didn't work for more than half.

Their fates took a turn for the better in 2006.

"In 2006, we began testing a drug called E7080 and found that several tumor types responded," says David Hong, M.D., in Investigational Cancer Therapeutics. "The response was particularly remarkable in thyroid cancer patients."

Quick progression from promising to proven
Hong says one of the unique things about MD Anderson is our ability to capitalize on such findings.

"When we see something promising in Phase I trials, MD Anderson has the experts and patients to quickly test it in larger Phase II trials to see if might help more patients," he says.

"The response continued to be very impressive in the Phase II trial, so we were able to move it into an even larger Phase III trial, which is the final stage of testing," says Maria Cabanillas, M.D., in Endocrine Neoplasia and Hormonal Disorders (ENHD), who ran the Phase II trial.

One of the patients who benefited from this drug in the Phase III trial was Hugh, who came to MD Anderson in 2010, and enrolled in the trial in 2012.

Hugh admits the once-a-day pill took a toll on his digestion. But after three months, scans showed his cancer had shrunk.

"This is a strong drug, and there are side effects that need to be carefully monitored," says ENHD's Mouhammed Amir Habra, M.D., who led MD Anderson's portion of the Phase III Trial. Habra was able to reduce Hugh's dosage to help reduce his stomach issues.

"Another benefit of being treated at MD Anderson is that we're experts in modifying the dosing so the drug's effectiveness is maintained while minimizing side effects," Habra says.

"Dr. Habra and his staff have been remarkable," Hugh says. "They have a thorough knowledge of the treatment and how to explain it. I'm very grateful for the overall care and concern I have received as a patient."
Help now, hope for the future
According to clinical trial results published in the New England Journal of Medicine, patients taking E7080, now called lenvatinib, went 18.3 months -- on average -- without their cancers progressing. This was 14.7 months longer than those who received a placebo treatment.

Importantly, 65% of people who took the drug responded.

"This is almost unprecedented for thyroid cancer patients with such advanced disease," Habra says.

Four patients had a complete response, meaning there were no signs of cancer following treatment, he adds.

"The overall response rate and the complete responses represent a very exciting area of further study that gives us hope of possibly offering a cure to a greater number of patients," says Steven Sherman, M.D., chair of Endocrine Neoplasia and Hormonal Disorders and associate vice provost for Clinical Research.
Early access to new therapies
Now that the drug's approved, patients everywhere can benefit.

"But our patients get the chance to benefit much earlier because we test new drugs," Hong says.

While the drug may continue its journey for other cancers, the FDA approval means Hugh will be able to get the drug closer to home and make fewer trips to MD Anderson.

"MD Anderson is different from any other hospital, so it's been worth every mile," says Hugh, who's also grateful for his wife's support and the hospitality of family and friends who've opened their homes for five years.

"The care you receive at MD Anderson is better, but also it's all the people and the atmosphere," Hugh adds. "Anytime I meet someone with cancer, the first thought I have is, 'You should be at MD Anderson.'"
Watch Dr. Sherman discuss lenvatinib:

A longer version of this story was originally published in Messenger, MD Anderson's bimonthly employee publication.